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To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.

NCT07760467 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-08-12

No results posted yet for this study

Summary

Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria, PNH

Interventions

DRUG

Part1: TUL321

orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg

DRUG

Part1: Placebo

Oral placebo capsules matching TUL321 capsules

DRUG

Part2: TUL321

orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID

DRUG

Part2: Placebo

Oral placebo capsules matching TUL321 capsules

Sponsors & Collaborators

  • Zhuhai United Laboratories Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guoping Yang · The Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-26
Primary Completion
2027-05-08
Completion
2027-05-08
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760467 on ClinicalTrials.gov